# ETHYLPARABEN (ethylparaben) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/ethylparaben
- **Standard INCI**: `ETHYLPARABEN`
- **KR MFDS Standard Name**: `에틸파라벤`
- **CAS No.**: `120-47-8`
- **EC / EINECS No.**: `204-399-4`
- **Origin**: `synthetic`
- **Functions**: 향료, 방부제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 에틸파라벤 |
| KR (Former Names) | 에칠파라벤 |
| EU (CosIng 1223/2009) | ETHYLPARABEN |
| US (PCPC / MoCRA INCI) | ETHYLPARABEN |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 羟苯乙酯 |
| JP (JCIA / MHLW QD) | ETHYLPARABEN  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `restricted`
- **EU (1223/2009)**: `restricted`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `5216`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`

- **KR** [limited]: ≤ 0.8% —  (화장품 사용제한 원료 정보 (식약처 오픈API · 안전기준 [별표2]))
- **EU** [limited]: ≤ 0.4% —  (Regulation (EC) No 1223/2009 Annex V — via CosIng (EU Commission))

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- Listed within general cosmetic GMP safety thresholds.

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 8
- **Max Process Temp**: ≤ 50°C
- **Synergy Pairings**: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL
- **Incompatibilities**: Verify phase compatibility under extreme pH or high electrolyte loads

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: ETHYLPARABEN | CAS No.: 120-47-8 | EC No.: 204-399-4
  - Origin: SYNTHETIC | Functions: , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [ETHYLPARABEN] · EU [ETHYLPARABEN] · CN [羟苯乙酯] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Ethylparaben is the ester of ethyl alcohol and p-hydroxybenzoic acid. It conforms to the formula: Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver ,  performance and structural formulation stability.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: RESTRICTED | EU: RESTRICTED | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 5216 (羟苯乙酯))
  - [KR / COMPOSITION / limited] (Max 0.8%): 
  - [EU / COMPOSITION / limited] (Max 0.4%): 
  - Official Safety & Historical Use Concentration (Layer 2): Quantum satis (QS) within standard cosmetic safety margins
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [cleanser_rinse] Typical range: 0.2 ~ 0.3% (Median 0.3%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, ELEMENTIS 4 · SEPPIC 1)) — Rinse-off cleanser & surfactant system modifier
  - [emulsion_cream] Typical range: 0.3 ~ 1.0% (Median 0.3%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, ELEMENTIS 3 · SEPPIC 2)) — Emulsion cream & lotion structural / conditioning agent
  - [sun_color] Typical range: 0.1 ~ 0.5% (Median 0.3%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, ELEMENTIS 3 · SEPPIC 2)) — Sun care & color cosmetics dispersion / sensory modifier
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water Phase or Cool-down Phase (< 45°C)
  - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM
  - Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads
  - Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: ETHYLPARABEN
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 35752233 (2022, Sci Total Environ): Molecular mechanism of ethylparaben on zebrafish embryo cardiotoxicity based on transcriptome analyses.
  - PMID 40602876 (2025, J Environ Sci (China)): Associations of pharmaceutical and personal care product chemical exposure with thyroid nodules and thyroid homeostasis
  - PMID 39424158 (2024, Chemosphere): Toxic Beauty: Parabens and benzophenone-type UV Filters linked to increased non-alcoholic fatty liver disease risk

## 6. Linked PubMed Literature
- [PMID: 35752233] Molecular mechanism of ethylparaben on zebrafish embryo cardiotoxicity based on transcriptome analyses. — *Sci Total Environ* (2022)
- [PMID: 40602876] Associations of pharmaceutical and personal care product chemical exposure with thyroid nodules and thyroid homeostasis — *J Environ Sci (China)* (2025)
- [PMID: 39424158] Toxic Beauty: Parabens and benzophenone-type UV Filters linked to increased non-alcoholic fatty liver disease risk — *Chemosphere* (2024)
- [PMID: 25265034] Ethylparaben affects lifespan, fecundity, and the expression levels of ERR, EcR and YPR in Drosophila melanogaster. — *J Insect Physiol* (2014)
- [PMID: 40466325] Melatonin and spermidine protect early mouse embryos from ethylparaben toxicity by restoring histone modifications and subcellular structures — *Ecotoxicol Environ Saf* (2025)
- [PMID: 38887664] Association Between Urinary Parabens and Sperm Quality in Nigerian Men: A Case-Control Study — *Int J Gen Med* (2024)
- [PMID: 41644853] From shelf to stream: occurrence of parabens in personal care products and urban waters of La Plata, Argentina — *Environ Monit Assess* (2026)
- [PMID: 41172944] Worldwide systematic analysis of dietary paraben exposure. A scoping review of sources and food categories — *Food Chem* (2025)
- [PMID: 40276354] Socioeconomic status in the association between use of personal care products and exposure to endocrine-disrupting chemicals in pregnant Taiwanese women — *Front Public Health* (2025)
- [PMID: 40164012] The utility of silicone wristbands in characterizing exposure to parabens found in commercial lotions — *Sci Total Environ* (2025)
- [PMID: 39955433] Young infants' exposure to parabens: lotion use as a potential source of exposure — *J Expo Sci Environ Epidemiol* (2025)
- [PMID: 39300872] Evaluation of dermal exposure to phthalates and parabens resulting from the use of hair relaxers — *Int J Environ Health Res* (2025)
- [PMID: 39270590] Profiling metabolites and exploring metabolism of parabens in human urine using non-target screening and molecular networking — *J Hazard Mater* (2024)
- [PMID: 38925470] A sustainable and innovative method to determine parabens in body creams for exposure and risk assessment — *Regul Toxicol Pharmacol* (2024)